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Smith & Nephew’s largest and most notable recall involved metal liners in its R3 Acetabular System. The liners caused devastating complications, such as metallosis and blood poisoning. The company also recalled components from its Redapt product line for high rates of adverse events. Several people harmed by the devices have filed lawsuits against the company. The lawsuits are pending and more claims are expected.

*Please seek the advice of a medical professional before discontinuing the use of this drug or medical device.

Smith & Nephew initiated a worldwide recall of the metal liner in its R3 Acetabular System in 2012 after reports of loosening, pain, device failure, infection, metal sensitivity and dislocation. Almost 4,000 of the metal liners were used in the United States between 2009 and the recall date.

The company also issued a recall of its Modular SMF and Modular Redapt Revision Femoral Hip System in 2016. The FDA reported that there were more than 2,000 units sold, and the recall was initiated because of “higher than anticipated complaint and adverse event trend.”

Complications and problems relating to the Smith & Nephew hips are a result of their metal-on-metal design. Numerous studies and FDA safety communications warned about the possible complications of these types of implants.

The metal liner of the R3 Acetabular is made of cobalt and chromium. The SMF and Redapt have titanium coatings and use cobalt-chromium neck stems. Cobalt-chromium implants have been shown to release metal ions into the body, and studies have revealed that chromium and cobalt ions are carcinogens linked to blood poisoning and genotoxicity (DNA damage).

The ions can cause local tissue reactions that destroy muscle and bone and spread to other organs. Cobalt has also been linked to cardiomyopathy, or heart muscle disease. The deterioration of bone and muscle around the implant can lead to loosening and device failure. All of these complications have been known to lead to metallosis, also known as metal poisoning.

In response to the unexpected complications, people harmed by Smith & Nephew hip implants have filed lawsuits against the company. The plaintiffs allege that Smith & Nephew failed to adequately test the implants, and it failed to warn of the risks associated with the devices. Several plaintiffs have requested federal courts to consolidate the cases to a single court.

R3 Acetabular System Recall

The R3 Acetabular System was released in Europe and Australia in 2007, and in 2009 the hip replacement system was launched in the United States. Smith & Nephew Orthopedics initiated a worldwide recall of the metal liner in its R3 Acetabular System on June 1, 2012, after reports of loosening, pain, device failure, infection, metal sensitivity and dislocation.

7,700 R3 devices implanted worldwide stat

About 7,700 R3 devices were implanted worldwide since 2009. The device experienced a higher than normal revision rate — 6.3 percent in four years compared with the average of 2.89 percent for primary total hip replacements. In the recall announcement, Smith & Nephew stated that the metal liner was not “performing as well” as the company expected and that it was “not satisfied with the clinical results.”

After the recall, the Smith & Nephew sent out “hazard alert” letters to doctors who had implanted the metal liners, claiming that the recall was a “precautionary step.”

Smith & Nephew also said it was unable to identify one single reason for the device failure, but there were reports of “infection, dislocation, metal sensitivity, loosening/lysis and fracture.” The letter further instructed doctors to follow up with their patients if they had received the liner.

Modular SMF and Modular Redapt Revision Femoral System Recall

Smith & Nephew originally marketed the Modular SMF Hip Stem as the MIS Hip Stem when it first hit the market in the U.S. in 2008, according to the company’s 510(k) premarket notification. The Redapt Revision Femoral System hit the U.S. market in 2012, also through the 510(k) process.

modular hip implant caution

On November 15, 2016, Smith & Nephew issued a voluntary recall for both the SMF and Redapt because of “a higher than anticipated complaint and adverse event trend,” according to the company’s urgent field safety notice. The recall affected devices shipped between October 2008 and July 2016.

The device maker said it would remove these implants and any related modular neck components from the market.

Smith & Nephew said the risk to patients could include adverse events linked to metal debris released by the implant that could lead to revision surgery. The company recommended that doctors monitor their patients for high levels of metal ions in the blood — levels above 7 parts per billion (ppb).

Smith & Nephew Lawsuits

Smith & Nephew hip lawyers are investigating new claims with the SMF and Redapt Hip Systems. Studies have already shown that a high number of R3 Acetabular Systems with the metal liner failed prematurely and required revision surgery.

Patients who received these recalled devices may have legal options against Smith & Nephew to receive compensation for revision surgery costs and pain suffered. Recipients of the metal liner option in this device are encouraged to evaluate their legal options even if they’re not experiencing complications, since metal ions in the blood may not always manifest symptoms in the early stages.

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People Who Filed Smith & Nephew Lawsuits

A New York woman, Susan Simon, claimed she experienced pain and clicking within three months of receiving an R3 acetabular hip replacement in 2010. In a lawsuit filed in New York state court in 2013, she claimed Smith & Nephew was negligent in its design, production and marketing of the implant.

Steven Zingler of Wisconsin filed a lawsuit against Smith & Nephew after his Birmingham Resurfacing femoral head and acetabular cup failed. Zingler received the hip implants during a resurfacing procedure in 2011. He had to undergo a revision surgery in 2016 because of hip pain and other complications.

Plaintiffs Request Consolidation of Smith & Nephew Cases

In February 2017, eight plaintiffs accusing Smith & Nephew of manufacturing and marketing faulty metal-on-metal hip implants requested the Judicial Panel on Multidistrict to form an MDL to consolidate hip implant lawsuits against the company.

Courts consolidate cases in multidistrict litigation when numerous cases have similar questions of fact and a similar defendant. The plaintiffs requested the panel to transfer 31 cases against Smith & Nephew to the United States District Court for the District of Maryland.

The cases involved Birmingham Hip Resurfacing devices and R3 metal-on-metal liners. According to Smith & Nephew’s 2015 financial reports, it set aside $203 million “for known, anticipated and settled metal on metal hip claims and associated legal expenses of $21 million.”

Author

Chris Elkins is a writer and researcher for Drugwatch.com. He’s worked for various newspapers and has writing experience in sports, health communication and public relations fields. He graduated from the University of West Florida with a master’s degree in Strategic Communication and Leadership, a graduate-level certificate in Health Communication Leadership and a bachelor’s degree in Journalism.

View Sources
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  2. Australian Therapeutic Goods Administration. (2012, June 13). Metal Liner Components of R3 Acetabular System. Retrieved from http://www.tga.gov.au/safety/alerts-device-r3-acetabular-metal-liner-120613.htm
  3. Cohen, D. (2012). How Safe Are Metal-on-metal Hip Implants? Retrieved from http://www.bmj.com/content/344/bmj.e1410
  4. Hirschler, B. (2012, June 1). Smith & Nephew Pulls Metal-on-metal Hip Component. Retrieved from http://articles.chicagotribune.com/2012-06-01/lifestyle/sns-rt-us-smithnephew-hipbre85010j-20120601_1_metal-on-metal-traditional-implants-smith-nephew
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  7. Smith & Nephew. (2016, November 15). Urgent Field Safety Notice: Medical Device Field Safety Corrective Action / Recall. Retrieved from http://www.bfarm.de/SharedDocs/Kundeninfos/EN/11/2016/09832-16_Kundeninfo_en.pdf;jsessionid=A90BEC524676E62D9943FE20B8C99B1C.1_cid350?__blob=publicationFile&v=1
  8. Stride, M. (2013, February 19). Smith & Nephew Sued Over Painful Hip Replacement. Retrieved from https://www.law360.com/articles/416588/smith-nephew-sued-over-painful-hip-replacement
  9. U.S. Food and Drug Administration (FDA). (2010, December 21). Warning letter. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm238125.htm
  10. U.S. Food and Drug Administration. (2017, January 4). Class 2 Device Recall Modular Redapt(TM) Hip Systems. Retrieved from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=151502
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